COVID-19 Vaccine Manufacturers Submit Appeals to FDA for Fourth Dose

The makers behind two of the largest COVID-19 vaccines, Pfizer, BioNTech, and Moderna, are seeking FDA approval for a fourth dose of their respective COVID-19 vaccines. Pfizer and BioNTech submitted an appeal to amend their Emergency Use Authorization (EUA) on March 15, 2022, while Moderna submitted one on March 17. Pfizer and BioNTech’s application is for a booster dose for adults 65 and older who have received an initial booster of any of the authorized or approved COVID-19 vaccines. According to a company press release, an analysis of Israeli Ministry of Health records found that confirmed infections were two times lower and rate of severe illness were four times lower among individuals who received an additional booster dose of the Pfizer-BioNTech COVID-19 vaccine administered at least four months after an initial booster dose relative to those who received only one booster dose.